Pelvic Floor DisordersNCT04655066
Evaluation of the Subjectively Perceived Pelvic Floor Function in Patients With Gynecological Tumors and Breast Cancer Under Systemic Tumor Therapy Using a Validated Questionnaire
An observational study of Pelvic Floor Disorders, run by St. Josefs-Hospital Wiesbaden GmbH at 1 site in Germany.
Trial summary
The multimodal therapy of gynecological malignancies and breast cancer often leads to an impairment of the pelvic floor function. This has a major impact on the quality of life of cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Floor Disorders
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to 31 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with gynecological tumors and breast cancer under systemic tumor therapy
Who may be able to join
- Breastcancer under tumor therapy
- Gynecological carcinoma under tumor therapy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
St. Josefs-Hospital Wiesbaden GmbH
Wiesbaden, 65189
About this study
Official title: PANTHERA-Studie "Pelvic Floor Disorders in Patients Under ANtineoplastic THERApy"
The multimodal therapy of gynecological malignancies and breast cancer often leads to an impairment of the pelvic floor function. This has a major impact on the quality of life of cancer patients. The aim of the study is to record and analyze the potential subjective impairment of the bladder, bowel and sexual function under systemic tumor therapy as well as possible influencing factors by means of validated disease-specific questionnaires. to find possible starting points for the prevention and treatment of the symptoms.
- Conditions
- Pelvic Floor Disorders
- Medical subject headings
- Pelvic Floor Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
The primary endpoint and basis for the sample size calculation is the incidence of clinically relevant deteriorations in the total score of pelvic floor function.
Bladder function, bowel function, sedimentation problems and sexual function, QoL are recorded using scores using the validated German pelvic floor questionnaire
Measured: 12 months
Secondary outcomes (1)
Secondary Endpoint
Type of tumor (breast cancer, ovarian cancer, cervical cancer, endometrial cancer, vulvar cancer), TNM stage, body weight, height, age, type of tumor therapy, number of previous therapies (chemoline), parity, mode of delivery, nicotine abuse, medication, previous surgery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Apr 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655066
- Sponsor's protocol ID
- PANTHERA
- Status last verified
- Sep 2025
- First submitted
- 19 Nov 2020
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PANTHERA-Studie "Pelvic Floor Disorders in Patients Under ANtineoplastic THERApy"
- ClinicalTrials.gov ID
- NCT04655066
- Acronym / sponsor ID
- PANTHERA
- Conditions
- Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbHUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The multimodal therapy of gynecological malignancies and breast cancer often leads to an impairment of the pelvic floor function. This has a major impact on the quality of life of cancer patients. The aim of the study is to record and analyze the potential subjective impairment of the bladder, bowel and sexual function under systemic tumor therapy as well as possible influencing factors by means of validated disease-specific questionnaires. to find possible starting points for the prevention and treatment of the symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with gynecological tumors and breast cancer under systemic tumor therapy
Key inclusion criteria (2 listed)
- Breastcancer under tumor therapy
- Gynecological carcinoma under tumor therapy
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Endpoint
Time frame: 12 months
The primary endpoint and basis for the sample size calculation is the incidence of clinically relevant deteriorations in the total score of pelvic floor function. Bladder function, bowel function, sedimentation problems and sexual function, QoL are recorded using scores using the validated German pelvic floor questionnaire
1 secondary outcome
Secondary Endpoint
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders, run by St. Josefs-Hospital Wiesbaden GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boris Gabriel, Prof. Dr. med. (+496111771500, bgabriel@joho.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.